Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
FDA device recall Z-2080-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.
- Action taken
- Letters were sent to Stryker branches and hospitals on August 17, 2005. If you have questions concerning this recall, contact Rita Intorrella at 201-831-5825 or Katherine Collins at 201-831-5025.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JEC
- Quantity affected
- 105 units
- Distribution
- The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide
- Date initiated
- 2005-08-17
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-24
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM (K971755) | Howmedica Corp. | 1997-07-17 |